The Senior Research Associate 2 Analytical Development within the ADQC department is responsible for executing analytical development activities related to bioassays, and potency assays supporting biologics programs from early phase to pivotal phase, regulatory submission, and commercialization. This role involves a high level of autonomy in method development, optimization, qualification, validation, method transfer to internal and external laboratories and ensure analytical readiness to support CMC milestones and regulatory submissions.
The incumbent must possess strong scientific judgment, hands-on laboratory expertise, and the ability to collaborate effectively with cross-functional teams and external partners in a highly regulated, fast-paced environment.
Duties and Responsibilities (Include but are not limited to):- Lead and perform hands-on analytical work for bioassays, and potency assays including method development, qualification, validation, transfer to internal and external QC labs, lifecycle management, and author associated documentation (method development reports, technical reports, qualification / validation /verification reports, method SOP etc.)
- Ensure analytical readiness for late-stage development, PPQ, and commercial launch of SAB-142 polyclonal antibody program.
- Lead and perform hands-on method troubleshooting, method optimization, method bridging, method performance monitoring, investigations (deviations, system suitability failure, OOT, OOS), CAPA, change control, continuous method improvement initiatives, and author associated documentation.
- Support reference standard and critical reagent qualification, qualification and testing of extended characterization bioassays, and forced degradation/stress sample study.
- Ensure analytical activities performed internally and at external partners are scientifically rigorous, comply with cGMP, ICH, USP, global regulations, and QbD principles, and align with industry's best practices and company quality standards.
- Support specification setting, and regulatory submissions.
- Manage general laboratory operations, including ordering supplies, and equipment qualification & maintenance.
- Support establishment of analytical non-GMP development area, and LIMS implementation.
- Partner closely with Quality Control and Quality Assurance to establish, maintain, and oversee analytical quality, GMP compliance infrastructure, and inspection readiness for internal and external analytical documents and data.
- Other duties/responsibilities as assigned.
Education/Experience/Skills:- Bachelor's degree with 8+ years of experience or master's degree with 4+ years of experience, in life sciences or a related discipline.
- Deep hands-on expertise in various bioassays, and potency assays including ELISA, cell-based potency methods, and flow cytometry for biologics.
- Experience with other ligand binding assays such as MSD, Biacore or Octet preferred but not required. Experience with microbial assays including growth promotion, bioburden, and endotoxin for biologics preferred, but not required.
- Experience with plasma or serum samples desired.
- Strong understanding of method validation, method transfer, and applicable guidelines (ICH, FDA guidance documents, USP/EP chapters etc.) with deep expertise in cGMP requirements.
- Experience in critical reagent qualification and stability monitoring for bioassays and potency assays.
- Utilizes established mathematical and scientific techniques including simple statistical analysis (mean, SD, %RSD) to compile and analyze data. Trend analysis /control charting desired.
- Strong written and verbal communication and technical writing skills and the ability to effectively present information in one-on-one, small groups and departmental meetings.
- Demonstrated proficiency in Microsoft Office applications (Word, Excel, PowerPoint and Outlook).
Working Environment and Travel:Duties will be performed in normal office, laboratory and BSL2 laboratory environments.
Travel is not typical for this position.
Physical Requirements: Ability to regularly move up to 10 pounds. Specific vision abilities required by this individual include close vision, peripheral vision, and the ability to adjust focus. The employee will view a computer monitor for long periods of time.
This job description will be reviewed periodically as duties and responsibilities change with business necessity. Primary and additional duties and responsibilities are subject to modification.
